EMBOLD™ Soft M001394250040300Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00191506026479), received between Jun 18, 2025 and Feb 23, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Break” (3 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 23, 2026Break; Difficult to Remove; Stretched; Material Protrusion/Extrusion; Migration

  IT WAS REPORTED THAT THE COIL FRACTURED INTERNALLY, REQUIRING ADDITIONAL INTERVENTION AND RESULTING IN AN UNRETRIEVED DEVICE FRAGMENT IN AN UNINTENDED LOCATION. AN EMBOLD SOFT 4X30 WAS SELECTED FOR USE TO TREAT A SPLENIC BLEED. DURING THE PROCEDURE, THE COIL FRACTURED AND UNRAVELED IN PORTIONS OF THE MAIN SPLENIC ARTERY AND INSIDE THE BASE NON-BOSTON SCIENTIFIC CATHETER. NUMEROUS ATTEMPTS WERE MADE TO SNARE THE TINY FILAMENT BUT WERE UNSUCCESSFUL. THE UNRAVELED MICRO COIL WAS FOUND TO EXTEND INTO THE DISTAL ABDOMINAL AORTA, JUST ABOVE THE BIFURCATION TO THE ILIAC ARTERIES. THE PHYSICIAN WAS ABLE TO CAPTURE THE FILAMENT WITH A SNARE, BUT THE FILAMENT BROKE FURTHER UP THE AORTA. THE PHYSICIAN WAS THEN ABLE TO REMOVE A LONG SEGMENT, BUT FAILED TO GRAB THE SMALL FILAMENT AFTER MULTIPLE ATTEMPTS. A SMALL FILAMENT OF THE COIL WAS ULTIMATELY LEFT WITHIN THE PATIENT. THE PATIENT WAS EXPECTED TO FULLY RECOVER. IT WAS FURTHER REPORTED THAT PRIOR TO THE COIL FRACTURING, THERE WAS DIFFICULTY ENCOUNTERED RETRACTING THE COIL INTO THE MICROCATHETER.

  Patient problems: Foreign Body In Patient

  MAUDE report 24416522 ↗
• InjuryFeb 9, 2026Break; Entrapment of Device; Difficult to Remove; Stretched; Malposition of Device; Difficult to Advance; Positioning Problem

  IT WAS REPORTED THAT A BREAK OCCURRED REQUIRING ADDITIONAL INTERVENTION. A 4 X 30 EMBOLD SOFT WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE TO TREAT A GASTROINTESTINAL (GI) BLEED IN THE PERITONEAL. DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PULL THE COIL BACK AND REMOVE IT WHEN THE CATHETER WAS GETTING PUSHED BACK. DIFFICULTY OCCURRED PULLING THE COIL OUT, SO IT WAS DECIDED TO PUSH THE COIL IN WITH THE PUSHER WIRE. THE COIL STRETCHED ALONG THE VESSEL BUT REMAINED IN PLACE WHEN THE RENEGADE STC MICROCATHETER WAS PULLED BACK TO REMOVE IT. A STRING OF FILAMENT FLOATING IN THE AORTA WAS NOTICED DURING A CONTRAST RUN. THE EMBOLD SOFT COULD NOT BE RELEASED SO THE BACK END OF THE PUSHER WIRE WAS CUT OFF. THE PHYSICIAN DECIDED TO GO BACK IN AND SNARE THE COIL AND FILAMENT STRING WHEN IT BEGAN TO LOOP AROUND THE TIP OF THE MICROCATHETER IN THE AORTA. THE COIL WAS LEFT IN PLACE SINCE THE FILAMENT APPEARED TO HAVE SEPARATED FROM THE COIL AT THAT POINT. A PROTECTIVE DEVICE WAS PUT IN PLACE SO THE FILAMENT WOULDN'T FLOW DISTALLY IN A VESSEL. THE FILAMENT WAS WRAPPED AROUND THE MICROCATHETER AND WAS ABLE TO BE REMOVED. WHEN REMOVING IT, PART OF THE PROTECTIVE DEVICE WAS BROKEN OFF WITH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24292544 ↗
• InjuryJul 18, 2025Break; Break

  IT WAS REPORTED THAT THE COIL BROKE. A 4MM X 30CM EMBOLD SOFT COIL WAS SELECTED FOR USE IN THE EMBOLIZATION OF A PSEUDOANEURYSM. DURING THE PROCEDURE, THE COIL DETACHED AND DISINTEGRATED AS IT WAS BEING RECAPTURED. A LOT OF FIBERED THREADS CAME APART. THE COIL WAS SNARED, AND THE BASE CATHETER WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22543492 ↗
• InjuryJun 18, 2025Premature Activation; Stretched; Difficult to Advance; Premature Activation; Stretched; Difficult to Advance

  IT WAS REPORTED THAT THE COIL STRETCHED AND PREMATURELY DEPLOYED, WHICH REQUIRED INTERVENTION. A 4MM X 30CM EMBOLD SOFT COIL WAS SELECTED FOR USE IN AN EMBOLIZATION PROCEDURE OF THE MODERATELY TORTUOUS SUPERIOR MESENTERIC ARTERY. DURING THE PROCEDURE, WHILE ATTEMPTING TO DEPLOY THE COIL INTO THE COIL PACK, THERE WAS RESISTANCE, AND ATTEMPTS WERE MADE TO PULL AND PUSH THE COIL TO RELEASE TENSION IN THE DELIVERY WIRE. IT WAS THOUGHT THAT THE COIL COULD HAVE BEEN CAUGHT IN THE COIL PACK. AN ATTEMPT WAS MADE TO PULL BACK ON THE MICROCATHETER; HOWEVER, IT WAS OBSERVED THAT THE COIL HAD STRETCHED OUT, AND THE COIL ENDED UP DEPLOYING INSIDE THE MICROCATHETER. THE COIL HAD TO BE SNARED OUT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285472 ↗